Acute Myeloid LeukemiaPhase 2NCT00373373
Efficacy of Sorafenib Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML
A Phase 2 study testing Sorafenib in people with Acute Myeloid Leukemia, run by University Hospital Muenster at 18 sites in Germany.
Trial summary
The primary purpose of the study is to determine, whether the addition of Sorafenib to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival). Read more about this study
- Who is it for?
- Ages 61 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Sorafenib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 18 sitesGermany
- Study dates
- Sep 2006to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 61 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML)
- Bone marrow aspirate or biopsy must contain >= 20% blasts of all nucleated cells, with the exception of AML FAB M6, where >= 30% of non-erythroid cells must be leukemic blasts
- Age >= 61 years
- Informed consent, personally signed and dated to participate in the study
- Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the Sorafenib treatment and for at least 3 months after the last administration of Sorafenib
Who cannot join
- Central nervous system manifestation of AML
- Cardiac Disease: Heart failure NYHA III° or IV°; active coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Chronically impaired renal function (creatinin clearance < 30 ml/min)
- Chronic pulmonary disease with relevant hypoxia
- Inadequate liver function (ALT and AST >= 2.5 x ULN)
- Total bilirubin >= 1.5 x ULN
Show all 22Show fewer
- Resting blood pressure (BP) consistently higher than systolic 160 mmHg and/or diastolic 95 mmHg
- Any severe concomitant condition which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol
- Uncontrolled active infection
- Concurrent malignancies other than AML
- Previous treatment of AML except hydroxyurea and up to 2 days <= 100 mg/m²/d cytarabine
- Known HIV and/or hepatitis C infection
- Evidence or history of CNS disease, including primary or metastatic brain tumors, seizure disorders
- Thrombotic or embolic events such as cerebrovascular accident or pulmonary embolism within 1 year of study entry
- Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
- History of organ allograft
- Concomitant treatment with kinase inhibitors, angiogenesis inhibitors and Myelotarg
- Patients with major surgery, open biopsy or significant traumatic injury within 4 weeks of start or first dose
- Serious, non-healing wound, ulcer or bone fracture
- Allergy to study medication or excipients in study medication
- Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- Patients who are not eligible for standard chemotherapy
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Germany18 sites
Charité Campus Benjamin Franklin, Med. Klinik III
Berlin, 12203
Klinikum Chemnitz GmbH, Klinik für Innere Medizin III
Chemnitz, 09113
Klinikum der Universität zu Köln, Klinik I für Innere Medizin
Cologne, 50937
Universitätsklinikum Carl Gustav Carus der TU Dresden, Medizinische Klinik I
Dresden, 01307
St. Johannes Hospital, Medizinische Klinik II
Duisburg, 47166
Universitätsklinikum Essen, Zentrum für Innere Medizin, Medizinische Klinik und Poliklinik für Hämatologie
Essen, 45147
Klinikum der J. W. Goethe-Universität Frankfurt am Main, Medizinische Klinik II
Frankfurt am Main, 60590
Allgemeines Krankenhaus St. Georg, Hämatologische Abteilung
Hamburg, 20099
Universitätsklinikum Heidelberg, Med. Klinik V
Heidelberg, D-69120
Klinikum der Johannes Gutenberg Universität, 3. Medizinische Klinik und Poliklinik
Mainz, 55101
Philipps Universität, Abteilung für Hämatologie, Onkologie und Immunologie
Marburg, 35043
Klinik für Hämatologie und Onkologie Klinikum Minden
Minden, 32423
TU München, Medizinische Klinik III
München, 81675
Universitätsklinikum Münster, Medizinische Klinik A
Münster, 48149
Klinikum Nürnberg, 5. Medizinische Klinik Einheit für Knochenmarktransplantation
Nuremberg, 90419
Universität Regensburg, Abteilung für Hämatologie und Internistische Onkologie
Regensburg, 93042
Robert-Bosch Krankenhaus Stuttgart
Stuttgart, 70376
Julius-Maximilians-Universität Würzburg, Medizinische Klinik und Poliklinik II
Würzburg, 97979
About this study
Official title: A Double-blind, Placebo-controlled, Randomized, Multi-center Phase II Trial to Assess the Efficacy of Sorafenib Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML
The primary purpose of the study is to determine, whether the addition of Sorafenib to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival).
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Sorafenib, Placebo
- Keywords
- Sorafenib, Acute Myeloid Leukemia, Flt3, AML, Kinase Inhibitor
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
2 x 400 mg/d
PlaceboDrug
Chemotherapy + Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Chemotherapy + Placebo Receives: Drug: Placebo |
| B | Active comparator | Chemotherapy + Sorafenib Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Event Free Survival of all AML patients
Secondary outcomes (9)
Median Event Free Survival of AML patients with Flt3-ITD mutations
Median Event Free Survival of the patients in each of the four strata (Flt3 Non-ITD/NPM1 WT, Flt3 Non-ITD/NPM1 mut, Flt3 ITD/NPM1 WT, Flt3 ITD/NPM1 mut)
Median Overall Survival of AML patients with Flt3-ITD mutations
Median Overall Survival of all AML patients
Rate of Complete Remission in all AML patients
Rate of Molecular Remission in all AML patients
Toxicity
Evidence of Minimal Residual Disease in all AML patients
Development of Biomarkers indicating the course of disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Hubert Serve, MD, Principal investigator, Klinikum der J.W. Goethe Universität Frankfurt, Med. Klinik II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373373
- Sponsor's protocol ID
- KKS/INNERE_A/AML2006
- Other IDs
- EudraCT Number: 2005-005966-35, Sorafenib in AML
- Status last verified
- Aug 2009
- First submitted
- 6 Sep 2006
- Last updated
- 19 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomized, Multi-center Phase II Trial to Assess the Efficacy of Sorafenib Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML
- ClinicalTrials.gov ID
- NCT00373373
- Acronym / sponsor ID
- KKS/INNERE_A/AML2006
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Sorafenib, Acute Myeloid Leukemia, Flt3, AML, Kinase Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Sep 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to determine, whether the addition of Sorafenib to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: PlaceboChemotherapy + Placebo |
| B | Active comparator | Drug: SorafenibChemotherapy + Sorafenib |
Who may qualify
- Ages
- 61 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with newly diagnosed AML (except APL) according to the FAB and WHO classification, including AML evolving from MDS or other hematologic diseases and AML after previous cytotoxic therapy or radiation (secondary AML)
- Bone marrow aspirate or biopsy must contain >= 20% blasts of all nucleated cells, with the exception of AML FAB M6, where >= 30% of non-erythroid cells must be leukemic blasts
- Age >= 61 years
- Informed consent, personally signed and dated to participate in the study
- Male patients enrolled in this trial must use adequate barrier birth control measures during the course of the Sorafenib treatment and for at least 3 months after the last administration of Sorafenib
Key exclusion criteria (22 listed)
- Central nervous system manifestation of AML
- Cardiac Disease: Heart failure NYHA III° or IV°; active coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Chronically impaired renal function (creatinin clearance < 30 ml/min)
- Chronic pulmonary disease with relevant hypoxia
- Inadequate liver function (ALT and AST >= 2.5 x ULN)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SorafenibAlso: Nexavar2 x 400 mg/d | Drug | B |
| PlaceboChemotherapy + Placebo | Drug | A |
Primary outcome
Median Event Free Survival of all AML patients
9 secondary outcomes
Median Event Free Survival of AML patients with Flt3-ITD mutations
Median Event Free Survival of the patients in each of the four strata (Flt3 Non-ITD/NPM1 WT, Flt3 Non-ITD/NPM1 mut, Flt3 ITD/NPM1 WT, Flt3 ITD/NPM1 mut)
Median Overall Survival of AML patients with Flt3-ITD mutations
Median Overall Survival of all AML patients
Rate of Complete Remission in all AML patients
Rate of Molecular Remission in all AML patients
Toxicity
Evidence of Minimal Residual Disease in all AML patients
Development of Biomarkers indicating the course of disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert Serve, MD principal investigator
Klinikum der J.W. Goethe Universität Frankfurt, Med. Klinik II
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib in people with Acute Myeloid Leukemia, run by University Hospital Muenster at 18 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Event Free Survival of all AML patients. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2009; AzTrials last refreshed its copy on 8 Nov 2026.